PoliomyelitisPhase 3NCT05850364
A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
A Phase 3 study testing Sabin Strain Inactivated Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sinovac Biotech Co., Ltd at 3 sites in 2 countries.
Trial summary
This study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Read more about this study
- Who is it for?
- Ages 42 to 47 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Polio
- What is being tested?
- Sabin Strain Inactivated Poliovirus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,442 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 May 2023to 13 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 47 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination records after birth; 4) Negative results in SARS-CoV-2 rapid antigen testing, within 24 hours before enrollment; 5) The participant's mother was tested negative for HIV, Syphilis, Hepatitis A, Hepatitis B infection during or before (during pregnancy) her child's enrollment to this study (the test result should be provided, and that obtained during pregnancy is acceptable).
- -
Who cannot join
- 1) History of polio vaccination (except the OPV at birth); 2) Prior vaccination with routine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4) Infants with premature labor (delivery before week 37 of gestation) and low body weight (birth body weight is <2500 g); 5) Infants with difficult labor at birth, asphyxiation rescue and history of nervous system injury; 6) Congenital malformation or development disorder, genetic defect, severe malnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8) Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer has received blood products before inoculation of the trial vaccine; 12) The volunteer has received other study drugs within 30 days before inoculation of the trial vaccine; 13) The volunteer has received live attenuated vaccines within 14 days before inoculation of the trial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 days before inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbation of chronic diseases within recent 7 days; 16) Significant acute disease or chronic infection within the previous 7 days or axillary temperature equal and more than 37.3℃ prior to vaccination in the present study; 17) The volunteer has any other factors which are unsuitable for participation in the clinical trial as judged by the investigators.
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Pakistan2 sites
Central Hospital
Gujranwala
The Aga Khan University
Karachi, 74800
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1000
About this study
Official title: A Multi-country, Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sabin Strain Inactivated Poliovirus Vaccine Administered With or Without Routine Infant Vaccines
This study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Thus, this study set up the concomitant vaccination schedule according to the real practice in study area. The primary hypothesis of this study is the seroconversion rate of polio vaccination when administered concomitantly with routine vaccines, is non-inferior to that when administered alone; the secondary hypothesis of this study is the seropositivity rate of diphtheria, tetanus, and pertussis when routine vaccines are administered concomitantly with sIPV, is non-inferior to that administered without sIPV.
Read the detailed description
This is a multi-country, multi-center, open-labelled, randomized, controlled, extended phase Ⅲ clinical trial. Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks of age, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks of age, and receive routine infant vaccines at 8,12,16 weeks of age. Participants in group S2 will receive routine infant vaccines at 6,10,14 weeks of age, and receive sIPV at 8,12, 16 weeks old.
For all the Participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on site. Guardians of participants will utilize the diary card to record solicited adverse events from the time of vaccination for 7 days post-vaccination of each dose. From the time of the first vaccination and 28 days post-vaccination of the last dose, unsolicited adverse events and any SAEs will be required to recorded in the diary card.
About 3 ml venous blood will be collected before the first vaccination and 28 days (+7) days after the last vaccination of sIPV or routine vaccines. Antibodies level will be determined using the collected sera for immunogenicity evaluation. Group C1 and S1 will be compared in terms of immunogenicity against polio; Group C2 and S2 will be compared in terms of immunogenicity against diphtheria, Tetanus, Pertussis, Hepatitis B, Hib and Pneumococcal.
- Conditions
- Poliomyelitis, Polio
- Being tested
- Sabin Strain Inactivated Poliovirus Vaccine
- Keywords
- Polio vaccines, Poliomyelitis Vaccine, Inactivated polio vaccine, Sabin Inactivated Poliovirus Vaccine (sIPV)
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabin Strain Inactivated Poliovirus VaccineBiological
Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks old, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks old, and receive routine infant vaccines at 8,12,16 weeks old. Participant s in group S2 will receive routine infant vaccines at 6,10,14 weeks old, and receive sIPV at 8,12, 16 weeks old.
| Study group | Role | What they receive |
|---|---|---|
| group C1 | Experimental | Co-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360) Receives: Biological: Sabin Strain Inactivated Poliovirus Vaccine |
| group C2 | Experimental | Co-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old Receives: Biological: Sabin Strain Inactivated Poliovirus Vaccine |
| group S1 | Experimental | Administration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old Receives: Biological: Sabin Strain Inactivated Poliovirus Vaccine |
| group S2 | Experimental | Administration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old Receives: Biological: Sabin Strain Inactivated Poliovirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines
Measured: 28 days
To evaluate the safety in terms of ARs (Vaccine-related AEs）
Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination
Measured: 7 days
Secondary outcomes (7)
To evaluate non-inferiority of immune response to diphtheria and tetanus antigens, when routine vaccines are administered concomitantly with sIPV
Seropositivity rate of IgG antibodies against diphtheria and tetanus, at 28 days after vaccination
Measured: 28 days
To evaluate non-inferiority of immune response to acellular pertussis antigens, when routine vaccines are administered concomitantly with sIPV
Seropositivity rate of IgG antibodies against pertussis toxin (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), at 28 days after vaccination
Measured: 28 days
To evaluate the immunogenicity against hepatitis B and Hib, when routine vaccines are administered concomitantly with sIPV
Sero-protection rate of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination and GMC of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination
Measured: 28 days
To evaluate the immunogenicity against pneumococcal, when routine vaccines are administered concomitantly with sIPV
Sero-protection rate of IgG antibodies against pneumococcal, at 28 days after vaccination and GMC of IgG antibodies against pneumococcal, at 28 days after vaccination
Measured: 28 days
To evaluate other immunogenicity of sIPV, when administered concomitantly with routine vaccines
GMT of neutralizing antibodies against polioviruses of three serotypes, at 28 days after three doses of vaccination
Measured: 28 days
To evaluate other immunogenicity against diphtheria, tetanus, acellular pertussis antigens
GMC of IgG antibodies against diphtheria, tetanus, acellular pertussis antigens, at 28 days after vaccination
Measured: 28 days
To evaluate the safety in terms of SAEs
Incidence of SAEs throughout the study
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start22 May 2023
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wasif A Khan, Dr., Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850364
- Sponsor's protocol ID
- PRO-sIPV-4001
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Islam MA, Zehra SM, Kazi Z, Ather S, Ahmed S, Timu RT, Hotwani A, Hossain MS, Tahir A, Xin Q, Han W, Khan WA, Saleem AF. A multi-center, open-labelled, randomized controlled extended phase III non-inferiority clinical trial to evaluate the immunogenicity and tolerability of poliomyelitis vaccine (Vero cells), inactivated, Sabin strains administered with or without routine infant vaccines. Vaccine. 2026 Aug 27;91:129095. doi: 10.1016/j.vaccine.2026.129095. Online ahead of print.
PubMed 42659917
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country, Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sabin Strain Inactivated Poliovirus Vaccine Administered With or Without Routine Infant Vaccines
- ClinicalTrials.gov ID
- NCT05850364
- Acronym / sponsor ID
- PRO-sIPV-4001
- Conditions
- Poliomyelitis, Polio
- Keywords
- Polio vaccines, Poliomyelitis Vaccine, Inactivated polio vaccine, Sabin Inactivated Poliovirus Vaccine (sIPV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,442 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Thus, this study set up the concomitant vaccination schedule according to the real practice in study area. The primary hypothesis of this study is the seroconversion rate of polio vaccination when administered concomitantly with routine vaccines, is non-inferior to that when administered alone; the secondary hypothesis of this study is the seropositivity rate of diphtheria, tetanus, and pertussis when routine vaccines are administered concomitantly with sIPV, is non-inferior to that administered without sIPV.
Detailed description
This is a multi-country, multi-center, open-labelled, randomized, controlled, extended phase Ⅲ clinical trial. Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks of age, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks of age, and receive routine infant vaccines at 8,12,16 weeks of age. Participants in group S2 will receive routine infant vaccines at 6,10,14 weeks of age, and receive sIPV at 8,12, 16 weeks old.
For all the Participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on site. Guardians of participants will utilize the diary card to record solicited adverse events from the time of vaccination for 7 days post-vaccination of each dose. From the time of the first vaccination and 28 days post-vaccination of the last dose, unsolicited adverse events and any SAEs will be required to recorded in the diary card.
About 3 ml venous blood will be collected before the first vaccination and 28 days (+7) days after the last vaccination of sIPV or routine vaccines. Antibodies level will be determined using the collected sera for immunogenicity evaluation. Group C1 and S1 will be compared in terms of immunogenicity against polio; Group C2 and S2 will be compared in terms of immunogenicity against diphtheria, Tetanus, Pertussis, Hepatitis B, Hib and Pneumococcal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group C1 | Experimental | Biological: Sabin Strain Inactivated Poliovirus VaccineCo-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360) |
| group C2 | Experimental | Biological: Sabin Strain Inactivated Poliovirus VaccineCo-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old |
| group S1 | Experimental | Biological: Sabin Strain Inactivated Poliovirus VaccineAdministration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old |
| group S2 | Experimental | Biological: Sabin Strain Inactivated Poliovirus VaccineAdministration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old |
Who may qualify
- Ages
- 42 to 47 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination records after birth; 4) Negative results in SARS-CoV-2 rapid antigen testing, within 24 hours before enrollment; 5) The participant's mother was tested negative for HIV, Syphilis, Hepatitis A, Hepatitis B infection during or before (during pregnancy) her child's enrollment to this study (the test result should be provided, and that obtained during pregnancy is acceptable).
- -
Key exclusion criteria (2 listed)
- 1) History of polio vaccination (except the OPV at birth); 2) Prior vaccination with routine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4) Infants with premature labor (delivery before week 37 of gestation) and low body weight (birth body weight is <2500 g); 5) Infants with difficult labor at birth, asphyxiation rescue and history of nervous system injury; 6) Congenital malformation or development disorder, genetic defect, severe malnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8) Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer has received blood products before inoculation of the trial vaccine; 12) The volunteer has received other study drugs within 30 days before inoculation of the trial vaccine; 13) The volunteer has received live attenuated vaccines within 14 days before inoculation of the trial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 days before inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbation of chronic diseases within recent 7 days; 16) Significant acute disease or chronic infection within the previous 7 days or axillary temperature equal and more than 37.3℃ prior to vaccination in the present study; 17) The volunteer has any other factors which are unsuitable for participation in the clinical trial as judged by the investigators.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sabin Strain Inactivated Poliovirus VaccineTotally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks old, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks old, and receive routine infant vaccines at 8,12,16 weeks old. Participant s in group S2 will receive routine infant vaccines at 6,10,14 weeks old, and receive sIPV at 8,12, 16 weeks old. | Biological | group C1, group C2, group S1, group S2 |
Primary outcome
To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines
Time frame: 28 days
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines
To evaluate the safety in terms of ARs (Vaccine-related AEs）
Time frame: 7 days
Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination
7 secondary outcomes
To evaluate non-inferiority of immune response to diphtheria and tetanus antigens, when routine vaccines are administered concomitantly with sIPV
Time frame: 28 days
To evaluate non-inferiority of immune response to acellular pertussis antigens, when routine vaccines are administered concomitantly with sIPV
Time frame: 28 days
To evaluate the immunogenicity against hepatitis B and Hib, when routine vaccines are administered concomitantly with sIPV
Time frame: 28 days
To evaluate the immunogenicity against pneumococcal, when routine vaccines are administered concomitantly with sIPV
Time frame: 28 days
To evaluate other immunogenicity of sIPV, when administered concomitantly with routine vaccines
Time frame: 28 days
To evaluate other immunogenicity against diphtheria, tetanus, acellular pertussis antigens
Time frame: 28 days
To evaluate the safety in terms of SAEs
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42659917Islam MA, Zehra SM, Kazi Z, Ather S, Ahmed S, Timu RT, Hotwani A, Hossain MS, Tahir A, Xin Q, Han W, Khan WA, Saleem AF. A multi-center, open-labelled, randomized controlled extended phase III non-inferiority clinical trial to evaluate the immunogenicity and tolerability of poliomyelitis vaccine (Vero cells), inactivated, Sabin strains administered with or without routine infant vaccines. Vaccine. 2026 Aug 27;91:129095. doi: 10.1016/j.vaccine.2026.129095. Online ahead of print.
- Individual participant dataSharing planned: No
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Poliomyelitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasif A Khan, Dr. principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sabin Strain Inactivated Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sinovac Biotech Co., Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan, Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.